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Wednesday, March 4th, 2026

Arcturus Therapeutics 2025 Annual Report: LUNAR and STARR mRNA Technology, KOSTAIVE COVID-19 Vaccine, and Rare Disease Pipeline Overview

Arcturus Therapeutics Holdings Inc. 2025 Annual Report: Key Highlights for Investors

Ticker: ARCT
Exchange: The Nasdaq Stock Market LLC


Key Points from the 2025 Annual Report

  • Company Overview: Arcturus Therapeutics Holdings Inc. is a messenger RNA (mRNA) medicines company focused on developing therapeutics for liver and respiratory rare diseases. The company is advancing its pipeline with ongoing Phase 2 clinical studies for two RNA therapeutic candidates targeting ornithine transcarbamylase (OTC) deficiency and cystic fibrosis (CF).
  • Product Pipeline:
    • OTC Deficiency (Liver Disease): The company is conducting Phase 2 trials for its mRNA candidate targeting this rare liver disorder.
    • Cystic Fibrosis (CF): Another mRNA candidate is in Phase 2 studies, aiming to address this life-threatening genetic disease affecting the lungs.
  • Strategic Collaborations:
    • CSL Seqirus Collaboration: Arcturus has a collaboration with CSL Seqirus focusing on infectious disease programs, including LUNAR-COV19 and LUNAR-FLU. The report highlights ongoing development activities under this partnership, which may include milestone payments and future royalties if products are commercialized.
    • Private and Governmental Partnerships: The company has arrangements with both private and governmental entities for development funding and market access. Some agreements allow for termination at the counterparty’s convenience, which could impact future revenues and program continuity.
  • Financial and Shareholder Highlights:
    • Common Shares Outstanding: As of February 27, 2026, the company had 28,423,069 shares of voting common stock outstanding.
    • Public Float: The aggregate market value of common equity held by non-affiliates as of June 30, 2025, is disclosed, which helps investors gauge liquidity and market capitalization.

Important Issues for Shareholders & Potential Price-Sensitive Information

  • Clinical Progress: The advancement of RNA therapeutic candidates for OTC deficiency and cystic fibrosis into Phase 2 is significant. Positive or negative clinical data from these studies could substantially impact the company’s valuation and share price.
  • Regulatory and Commercialization Path: The report emphasizes the company’s efforts to obtain and maintain regulatory approval for its product candidates. Any updates regarding regulatory submissions, approvals, or delays will be highly material to investors.
  • Collaborations and Revenue Potential: The partnership with CSL Seqirus and other governmental entities could provide non-dilutive funding, milestone payments, royalties, and expanded market opportunities. However, shareholders should note that certain agreements can be terminated for convenience, introducing potential uncertainty in future cash flows.
  • Competitive Landscape and Market Size: Market acceptance, the success of competing therapies, and the growth potential in rare liver and respiratory disease segments are highlighted as factors that could affect future revenues. Any shifts in competitive positioning or new market entrants should be monitored closely.
  • Liquidity and Going Concern: The company notes its need to obtain and deploy funding efficiently and continue as a going concern. Shareholders should watch for any capital raises, debt issuance, or changes in cash runway, as these will affect dilution and financial stability.
  • Legal and Regulatory Risks: The company acknowledges the possibility of costly litigation with shareholders, former executives, or others, which could have reputational and financial impacts if such events arise.
  • No Restatements or Error Corrections: The company reports no corrections of errors to previously issued financial statements, and no required recovery of incentive-based compensation, which provides confidence in the accuracy of financial reporting.
  • Corporate Structure & Status: Arcturus is not a well-known seasoned issuer, not an emerging growth company, and not a shell company. These statuses affect disclosure, governance, and regulatory requirements.

Potential Catalysts and Share Price Movers

  • Upcoming Clinical Readouts: Results from the ongoing Phase 2 trials in OTC deficiency and cystic fibrosis could significantly move the share price, depending on efficacy and safety outcomes.
  • Regulatory Milestones: Any news regarding IND (Investigational New Drug) approvals, regulatory submissions, fast-track designations, or marketing authorizations would likely be material.
  • New and Existing Collaborations: Announcements of new strategic partnerships or expansion of existing agreements with CSL Seqirus or governmental agencies could impact the company’s funding position and growth prospects.
  • Financial Updates: Capital raises, changes in cash position, or statements on the company’s ability to continue as a going concern are all potentially price-sensitive.

Other Disclosures and Information

  • Trademarks: The Arcturus logo and other company trademarks remain the property of Arcturus Therapeutics Holdings Inc. All other trademarks mentioned are the property of their respective owners.
  • Reference Materials: Market data, forecasts, and other information are based on third-party publications, industry sources, and the company’s internal research. The company has not independently verified all third-party data.
  • Forward-Looking Statements: The report contains forward-looking statements subject to significant risks and uncertainties, including those related to clinical development, regulatory approvals, commercialization, and financial condition.

Disclaimer

This article is a summary and analysis of the Arcturus Therapeutics Holdings Inc. 2025 Annual Report and is intended for informational purposes only. It does not constitute investment advice. Investors should perform their own due diligence and consult with financial advisors before making any investment decisions. The information provided may include forward-looking statements that are subject to risks and uncertainties. Actual results may differ materially from those anticipated or projected.

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